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Design of experiments enables engineers to demonstrate or understand a process while providing information required for achieving regulatory compliance.A valuable method for predicting process variability, design of experiments (DOE) allows...
On Thursday, December 4 at BIOMEDevice San Jose, Thor Rollins, in vivo biocompatibility section leader at Nelson Laboratories Inc. (Salt Lake City, UT), will speak on "Materials Selection and Sampling Techniques for Biocompatibility (ISO 10993)."...
A nine-day FDA inspection at Alpha Medical Instruments in Mission Viejo, CA, in August found Quality System Regulation violations in the firm’s manufacturing of angiographic balloon catheters.
An FDA inspection at Infopia in Anyang-si, South Korea, has found Quality System Regulation violations in the firm’s manufacturing of several glucose and lipid devices.
To compete, grow, and innovate, manufacturers should adopt a cloud-based enterprise resource planning system that integrates quality management functionality.
The Blue Earth, MN, firm's violations include failing to establish adequate procedures for acceptance of in-process product and failing to establish adequate procedures for corrective and preventive action.